CMC Product Manager

Mission statements

This role will manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for licensed and clinical products for the Sanofi portfolio. This position will provide input into the product strategy and to the direction provided to commercial and clinical teams.

Duties & Responsibilities

  • Responsible for developing innovative regulatory strategy and assuring this regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality
  • Coordinate with our global manufacturing sites, integration of regulatory strategy with those sites and communication to senior management. Possibility to lead or coach a team of regulatory professionals
  • Create collaborative working relationships with Global Regulatory Affairs (scopes: corporate, regional, national), Technical and Quality Groups within R&D and Industrial Affairs, External Alliance Partners, Project Direction/ Management, Regulatory Health Authorities
  • Manage new applications for biologics through planning, preparation, submitting, reviewing support for product dossiers
  • Lead the license maintenance with annual reports (US, Canadian NDC and YBPR, license and renewals) and site renewals (ex. Japan Accreditation)
  • Be in charge of the regulatory strategy development by ensuring the preparation and review of submissions, the technical review of site supporting documents (CoA, SMF, MBR, SOPs), the notification of Reg Ops for publishing and dispatch to Health Authorities, the interaction with EMA and EU member states BoH on CMC topics
  • Evaluate Global Regulatory CMC strategies and risks to develop projects and/or marketed products.
  • Work closely with the CMC teams to achieve implementation of appropriate regulatory strategies with regards to the financial impact and all identified risks

Qualifications / Experience

  • Bachelor or ideally Master’s scientific, healthcare or life sciences degree, RAC certification is an asset
  • 5+ years of experience in a regulatory function within a matrix environment
  • Knowledge and experience of EU, FDA, and global regulations
  • Experience with biological products
  • Communication, leadership, team spirit, organizational skills
  • IT skills: MS Word, Excel, PowerPoint, MS Project, and Trackwise
  • Experience with Veeva Vault RIM or equivalent RIM systems desired.
  • Oral and written fluency in English
  • Demonstrated ability to establish effective working relationships in different functions.
  • Strong interpersonal skills
  • Strong organization and communication skills within a matrixed organization
  • Demonstrated ability to effectively influence leaders and team members. 
  • Business acumen expert knowledge
  • Track record with workforce capacity planning / productivity
  • Success in developing and managing a strategy and planning process
  • Ability to manage in a matrix environment

Sector(s):

  • Healthcare, Pharmaceutical Industry
  • Healthcare Specialist
  • Clinical Researcher

Experience required:

  • 5-10 years professional experience

Required Qualification:

  • College degree

Required language level:

  • English (higher advanced/fit for negotiation)

Employment type:

  • Full time
  • Employee status

Job location:

Budapest

How to apply/ contact information:

Apply via "Jelentkezem" button underneath!

Cégnév: Chinoin Zrt. / SANOFI AVENTIS
Állás helye:
Állás-kategóriák:
Állásnév:
HASONLÓ ÁLLÁSOK
Műszaki termékmenedzser Jász-Nagykun-Szolnok megye

Precíziós gazdálkodási eszközök termék portfóliójának menedzselése Beszerzési és értékesítési stratégia meghatározása Meglévő partnerekkel való ... »

ÁLLÁS MEGTEKINTÉSE
Product Manager Pest megye

Partnerünk majdnem 30 éves múlttal rendelkező, nemzetközi vállalat. KEY ACCOUNT MANAGER munkakörbe keressük azt a kollégát aki műszaki ... »

ÁLLÁS MEGTEKINTÉSE
Product Manager Pest megye

Partnerünk majdnem 30 éves múlttal rendelkező, nemzetközi vállalat. Termék Manager munkakörbe keressük azt a kollégát aki műszaki termék ... »

ÁLLÁS MEGTEKINTÉSE